HI-CHART: A Phase I/II Study on the Feasibility of High-Dose Accelerated Conformal Radiotherapy in Patients With Inoperable Non-Small Cell Lung Cancer.
Non-small cell lung cancer is still the most common cancer and the main cause of cancer
death. Treatment of choice for these patients is often radiotherapy, which results in an
overall 5-year survival rate between 5 and 10%. The addition of chemotherapy improves
survival by a few percentages and is therefore considered standard treatment for patients
with stage III disease.
However, several factors have been identified that have an impact on the local control but
also on survival.
1. There is a dose-effect relationship. A higher dose results in a better survival rate.
However, higher radiation doses are currently not delivered with conventional radiation
due to the tolerance of normal tissue.
2. The time factor plays an important role in radiotherapy. Prolonging the overall
treatment time decreases the outcome of radiotherapy. Radiobiological modelling of data
shows that the overall treatmetn time (OTT) should be kept below 4 weeks. Results from
studies support this conclusion.
So, probably the best results will be achieved when a very high radiation dose can be
delivered within 4 weeks, without severally damaging normal tissue.
In order to achieve this goal, an hyperfractionated accelerated treatment regimen together
with a technically very advanced radiation technique to avoid as much normal tissue as
possible, will be used in this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rinus Wanders, MD
Maastricht Radiation Oncology (MAASTRO clinic)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)